Medical skin-marking device

ABSTRACT

A sterile, disposable skin-marking device for applying a marking agent to the skin of a patient who is to undergo radiation therapy. The skin-marking device has a flexible housing that contains a rupturable cartridge containing the marking agent. The application end of the device is provided with a LUER-LOK coupler. A needle of appropriate size, with a LUER-LOK base, is selected and inserted into the LUER-LOK coupler, with the sheath still intact and in place. The cartridge is then ruptured by flexing or compressing the housing,. The marking agent flows into the needle, and, after removing the protective needle sheath, the needle is used to penetrate the skin of the patient to apply the marking agent to mark treatment set-up points.

BACKGROUND INFORMATION

1. Field of the Invention

The invention relates to the field of marking an area on the body of apatient as a guide for medical treatment. More particularly, theinvention relates to marking the skin of a patient in preparation formedical treatment. Most particularly yet, the invention relates toapplying marks to the skin of a patient undergoing radiation therapy.

2. Description of the Prior Art

Markings, also often referred to as tattoos, are typically applied tothe skin of a patient in preparation for radiation therapy or othermedical treatment, as a means of clearly delineating the location oftreatment set-up points. Traditionally, the marking is done by applyinga drop of marking agent to the surface of the patient's skin and thenpenetrating the skin with a needle to allow the marking agent to flowunder the surface of the skin. The size of the needle used can varywidely, some technicians preferring to work with a larger needle, otherswith a smaller needle. When marking the skin in this way, it is criticalthat the marking agent, such as India ink, as well as the needle tip besterile. Furthermore, it is highly desirable to have a disposableneedle, to eliminate the possibility of passing pathogens from oneperson to another and to eliminate the need for sterilizing the needles.It is also desirable to have a marking device that will accept astandard needle that is typically kept in stock in a healthcarefacility, in a range of needle gauges.

Sarath et al. (U.S. Pat. No. 4,798,582; 1989) discloses a needlecartridge that is threadably mounted onto the drive shaft of anelectrical tattooing instrument. Chasan (U.S. Pat. No. 5,496,304; 1996)discloses a surgical marking pen for drawing lines on the skin of apatient. The Chasan device has a handle and a fluid reservoir thatcommunicates with a pinwheel that penetrates the skin. Arranged aroundthe circumference of the pinwheel is a plurality of needle tips thatpuncture the skin, leaving a tattooed line in the epidermis of the skin.The marking pen disclosed therein may be disposable, or refillable. Thedisadvantages of these devices are that they require special equipmentor special needles. The device disclosed in Chasan has the furtherdisadvantage of not being suited for placing individual circular ortriangular markings on the skin, that is, it is a device that drawslines, rather than marks points.

Rosen (U.S. Pat. No. 6,056,737; 2000) discloses a disposableskin-marking device that is provided in a sealed sterile package and isdiscarded after a single use. The skin-marking device has a felt-tip niband includes a glass cartridge containing marking agent inside aflexible housing. The cartridge is ruptured by bending or compressingthe housing, whereupon the marking agent flows into the nib of the pen.This type of device is not suited to applying a marking agent under thesurface layer of the skin.

Therefore, what is needed is a skin-marking device for applying amarking agent beneath one or more layers of the skin. What is furtherneeded is such a device that provides a sterile supply of the markingagent and is disposable after a single use. What is still further neededis such a device that accepts a standard general-purpose needle in arange of needle gauges.

SUMMARY OF THE INVENTION

For the above cited reasons, it is an object of the invention to providea disposable sterile skin-marking device that carries a cartridge ofsterile marking agent and uses a needle to apply the marking agentbeneath one or more layers of the skin surface. It is a further objectof the invention to provide such a skin-marking device that will accepta standard needle in a range of needle gauges.

The object of the invention is achieved by providing a skin-markingdevice that has a flexible housing provided with a quick-coupling typeof coupler that is adapted to receive a needle provided with a base thatmates with the quick-coupler on the housing. In the PreferredEmbodiment, the quick-coupler is a LUER-LOK type coupler and the housinghas a female coupler and the needle base a male coupler. Any one of arange of needles provided with a LUER-LOK type base can be inserted intothe needle end of the skin-marking device. Alternative embodiments mayinclude other types of standard coupling mechanisms that needles aretypically provided with when supplied to healthcare facilities. Thus,needles in a range of needle gauges are available to the technicianpreparing the patient for the radiation therapy and he or she can choosethe preferred needle size. The device is supplied packaged in sterile,protective material.

The flexible housing contains a sealed rupturable cartridge thatcontains sterile marking agent, such as India-ink. The cartridge isruptured by flexing or compressing the housing, while the needle sheathis still intact and in place. The marking agent flows into the needleand, after removing the sheath, the needle is used to penetrate the skinof the patient to apply the marking agent. The cartridge containssufficient marking agent to apply multiple tattoos to a single patient.The entire device including needle is discarded after use.

The skin-marking device is provided as a sealed, sterile unit thatincludes the housing, the cartridge with marking agent, a seal cap atthe end of the housing, a LUER-LOK tip for receiving a needle, and aLUER-LOK cap to seal the needle end of the skin-marking device beforeuse. When ready to apply the tattoo to the patient, the LUER-LOK cap isremoved, a needle with a LUER-LOK base is fitted into the LUER-LOK tipof the device, and the housing flexed to rupture the sealed cartridgewith the marking agent. The marking agent flows into the needle, and thetechnician can now remove the needle sheath and apply the marking agentbeneath one or more layers of the skin to precisely mark the locationfor treatment setup.

In a first alternative embodiment, the quick-coupler on the housing ofthe skin-marking device is provided with a needle tip that is shortenough that a needle with a base that mates with the quick-coupler maybe fitted over the short needle. This is an advantage in that theskin-marking devices may be provided with a typical gauge needle tip forskin-marking, but a technician who has a preference for a longer needleor a different gauge needle may attach the preferred needle to theskin-marking device without having to remove the short needle tip.

In a further alternative embodiment of the present invention, theskin-marking device can be supplied as a disposable, ready-to-use unitthat includes a flexible housing with a cartridge of sterileskin-marking agent, without a quick-coupler, and already fitted with astandard gauge needle for skin-marking.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the skin-marking device of the present invention as it isprovided to the healthcare facility that applies the marking agent.

FIG. 2 shows the skin-marking device being readied for an application ofthe marking agent to the skin of a patient.

FIG. 3 shows a first alternative embodiment of the skin-marking deviceaccording to the present invention, having a short needle tip, overwhich a standard needle can be attached.

FIG. 4 shows a second alternative embodiment of the skin-marking deviceaccording to the present invention having a housing without aquick-coupler, and a fixed needle tip

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 shows the preferred embodiment of a skin-marking device 10according to the present invention. The skin-marking device 10 comprisesa flexible housing 1, a LUER-LOK coupler 2, a LUER-LOK seal cap 3, asealed cartridge 4 containing sterile marking agent, such as India-ink,and an end seal cap 5. In the Preferred Embodiment, the LUER-LOK sealcap 3 and the end seal cap 5 are plastic caps that snap onto therespective ends of the housing 1 to effectively seal the cartridge inthe housing 1. The LUER-LOK coupler 2 is adapted to receive a needle 6(shown in FIG. 2) or other device that has a LUER-LOK base that mateswith the LUER-LOK coupler 2.

FIG. 2 shows the Preferred Embodiment of the skin-marking device 10being readied for an application of marking agent. As can be seen, heLUER-LOK seal cap 3 has been removed from the skin-marking device 10.For purposes of illustration, the needle 6 with a LUER-LOK base hasalready been removed from a protective, sterile-seal sheath (not shown)and is ready to be inserted into the LUER-LOK coupler 2 of theskin-marking device 10.

The technicians who apply the skin markings to the patients may have apreferences for a particular size needle. Typically, the particulartreatment facility will stock needles 6 having a LUER-LOK base in arange of sizes, to be used for a variety of different applications. Theparticular technician applying the skin-marking selects his or herpreferred needle size, fits the needle 6 onto the skin-marking device10, flexes or compresses the flexible housing 1 while the needle sheathis still in place to rupture the sealed cartridge containing the markingagent, and then removes the sheath to apply the marking agent to thedesired location on the skin of the patient. The needle 6 is aconventional needle that is typically supplied to health carefacilities, enclosed in a rigid, sterile protective sheath that has aseal that is broken before use. Since the needle 6 and its sheath is aconventional device, well-known in the field, and does not constitutethe claimed novelty of the present invention, the needle is not shown inany detail in the FIGURES and the needle sheath is not shown at all.

FIG. 3 shows a skin-marking device 10A that is a first alternativeembodiment of the skin marking device 10 according to the presentinvention. The same reference designations are used to identifycomponents of the device 10A that are identical to the components of theskin-marking device 10. As can be seen, a short needle tip 7 is providedin the LUER-LOK coupler 2 of the flexible housing 1. A needle 6 that hasa LUER-LOK base that mates with the LUER-LOK coupler 2 can be insertedinto the LUER-LOK coupler 2, without first removing the short needle tip7.

FIG. 4 shows a skin-marking device 10B that is a second alternativeembodiment of the skin-marking device 10 of the present invention.Again, the same reference designations are used to identify componentsof the device 10B that are identical to components of the skin-markingdevice 10. In this second alternative embodiment, the skin-markingdevice 10B is provided as a ready-to-use, disposable skin-marking devicethat does not have a quick-coupler, but a fixed needle base 9, and isprovided with a needle tip 8 that is a standard gauge for marking skinin preparation for treatment.

It should be understood that the embodiments mentioned herein are merelyillustrative of the present invention. Variations in construction anduse of the present invention may be contemplated in view of thefollowing claims without straying from the intended scope and field ofthe invention herein disclosed.

What is claimed is:
 1. A skin-marking device for applying a markingagent beneath a surface layer of the skin, wherein said device is usablewith a conventional, quick-coupling skin-penetrating needle typicallyused in healthcare facilities for a variety of applications, saidskin-penetrating needle having a male quick-coupler base for attachingsaid skin-penetrating needle to a conventional syringe, saidskin-marking device comprising: a flexible housing that is connectableto a single skin-penetrating needle, said housing having a first end anda second end, wherein said first end is provided with a femalequick-coupler for mating with said male quick-coupler base of saidskin-penetrating needle; and a cartridge of marking agent; wherein saidcartridge is insertable within said housing and wherein said first endand said second end each have a seal means for providing an effectiveseal of said housing to maintain sterility of said marking agent.
 2. Thedevice according to claim 1, wherein said seal means includes aremovably attachable seal cap.
 3. The device according to claim 2,wherein said removably attachable seal cap is a quick-coupling cap thatcovers said first end and is easily removable.
 4. The device accordingto claim 1, wherein said cartridge is a rupturable cartridge that isruptured by flexing said housing.
 5. The skin-marking device accordingto claim 1, further including a single short needle tip that is anintegral part of said first end.
 6. The skin-marking device of claim 5,wherein said skin-penetrating needle is couplable with said femalequick-coupler on said first end, without first removing said shortneedle tip from said skin-marking device.
 7. A method of applyingmarking agent beneath a surface of the skin of a patient, using theskin-marking device of claim 1, said method comprising the steps of: a.providing a set of needles of various sizes, each of said needles beingsaid skin-penetrating needle having said conventional quick-couplerbase; b. providing said skin-marking device of claim 1; c. removing saidseal means from said first end; d. selecting a needle of appropriatesize from said set of needles; e. inserting said quick-coupler base ofsaid needle into said female quick-coupler; f. flexing said housing ofsaid device so as to rupture said cartridge; and g. removing aprotective needle sheath from said needle and penetrating the skin of apatient with said needle.
 8. The device according to claim 1, whereinsaid device is discarded after use on a single patient and said sealmeans on said second end provides a permanent seal.